Pain, InflammatoryPhase 1NCT03485365
A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA)
A Phase 1 study testing GSK3858279 IV and GSK3858279 SC in people with Pain, Inflammatory, run by GlaxoSmithKline at 5 sites in 3 countries.
Trial summary
This study is the first administration of GSK3858279 in humans and will be conducted in two parts: Part A will consist of a single ascending dose escalation design to evaluate safety, tolerability, PK, TE and immunogenicity of either a single intravenous (IV) or a single subcutaneous (SC) dose. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Inflammatory
- What is being tested?
- GSK3858279 IV and GSK3858279 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 17 May 2018to 12 Sep 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Part A:
- Participants between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body weight within the range 50 to 100 kilogram (kg) and body mass index (BMI) within the range 18 to 32 kilogram per meter square (kg/m^2) (inclusive).
- Male participants are eligible to participate if they agree to the following for at least 28 weeks after the dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier as detailed below: agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- A female participant is eligible to participate if she is of non-reproductive potential.
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- Capable of giving signed informed consent.
- For Part B:
- Age between 40 and 75 years of age inclusive, at the time of signing the informed consent.
- OA of the index knee as defined by symptomatic for >=6 months with a clinical diagnosis of OA as per American College of Rheumatology (ACR) clinical diagnosis criteria.
- Average of daily pain score >=4 and <=9 by 11 point NRS (0 to 10) in index knee over 7 days prior to dosing (Day-7 to Day-1). Data should be recorded on at least 5 of 7 occasions by the participant to obtain a valid Baseline value.
- Kellgren and Lawrence (KL) score >=2 on X-ray obtained during screening. In addition, for participants with bilateral Knee OA, the index knee is determined at Baseline as the participant reported most painful knee over the 4 weeks prior to Baseline.
- A history of insufficient pain relief from, or inability to tolerate, or contraindication to, oral Non-steroidal anti-inflammatory drugs (NSAIDs).
- A participant must be willing and able to understand and participate in all scheduled evaluations and to complete all required tests and procedures including the use of patient diaries. This will be judged by the Investigator during the screening period.
- BMI within the range 19-34.9 kg/m^2 (inclusive)
- Male participants are eligible to participate if they agree to the following for at least 28 weeks after the dose of study intervention: refrain from donating sperm PLUS either: Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use contraception/barrier as detailed: Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- A female participant is eligible to participate if she is of non-reproductive potential.
- Capable of giving signed informed consent.
Who cannot join
- For Part A:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Personal or family history of cardiomyopathy.
- Abnormal blood pressure at screening as determined by the investigator.
- History of symptomatic herpes zoster.
- Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test.
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- Significant allergies to humanized monoclonal antibodies as per principal investigator's and GlaxoSmithKline (GSK) medical monitor's judgments.
- History or evidence of clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- Lymphoma, leukemia, or any malignancy except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Alanine transaminase (ALT) >1.5 times upper limit of normal (ULN).
- Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Corrected QT (QTc) >450 milliseconds (msec).
- History of Stevens Johnson Syndrome.
- Known immunodeficiency.
- Participants with a chronic infection (example given [e.g.], osteomyelitis), who have been receiving treatment within three months prior to dosing or individuals with an active infection.
- Previous or current history of bleeding diathesis.
- Previous history of hypertrophic or keloid scarring.
- Intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing until final follow-up visit.
- Live vaccine(s), or plans to receive such vaccines within 1 month of screening until final follow-up visit.
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Treatment with antiplatelet or anticoagulant agents within 7 days of dosing.
- Major surgery (as per investigator's judgment) within 3 months prior to dosing.
- Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 3 months.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current enrolment or past participation in any other clinical study involving an investigational study intervention or any other type of medical research within the last 30 days, 5 half-lives or twice the duration of the biological product before dosing day in the current study.
- Presence of Hepatitis B surface antigen (HBsAg) at screening.
- Presence of the Hepatitis B core antibody (HBcAb) at screening.
- Positive Hepatitis C antibody test result at screening.
- Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
- Abnormal clinically significant echocardiogram at screening, as assessed by the investigator.
- Cardiac troponin levels out of normal range at screening.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >21 units for males and >14 units for females. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Smokelyser levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Regular use of known drugs of abuse.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- For Part B:
- Diagnosis of one or more of the following, as per medical records: Significant pain in any joint other than the index knee or any referred pain that would impact ability to assess pain in the index knee as per investigator's judgement (Pain in other locations should be less than pain in target knee).
- Current inflammatory arthritis such as rheumatoid arthritis, autoimmune disorder affecting joints, seronegative spondyloarthritis, gout or pseudogout in any joint (defined as acute episodic attacks of swollen, painful joint in a participant with X-Ray chondrocalcinosis or calcium pyrophosphate dehydrate [CPPD] crystals).
- History of gout or pseudogout in any large joint.
- History or evidence of infectious arthritis, Paget's disease, ochronosis, Wilson's disease, primary osteochondromatosis, osteonecrosis and other causes of significant joint disease osteoarthritis as determined by the investigator.
- History of fibromyalgia.
- Current immunodeficiency diseases.
- Current osteoporosis with symptomatic vertebral or hip fractures.
- Current regional pain syndromes caused by lumbar or cervical compressions with radiculopathy.
- History of significant medical illness in the opinion of the investigator would interfere with the study procedures and / or assessments.
- Symptomatic herpes zoster within 3 months prior to screening.
- Evidence of active or latent TB as documented by medical history, examination and TB testing: either a positive tuberculin skin test (TST; defined as a skin induration >5 millimeter (mm) at 48 to 72 hours, regardless of Bacillus Calmette-Guerin (BCG) or other vaccination history) or a positive (not indeterminate) QuantiFERON test.
- History of significant allergies to humanized monoclonal antibodies.
- History or evidence of clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linearIgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis.
- History of malignancy within the last 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- ALT >1.5 times the ULN.
- Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent)
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- QTc >450 msec or QTc >480 msec in participants with bundle branch block.
- History of primary cardiomyopathy and any major cardiac or vascular event within the last 6 months, including and not limited to myocardial infarction, unstable angina, cerebrovascular event, peripheral arterial or venous thrombosis.
- Current or history of renal disease, or estimated creatinine clearance <60 mL/minute/1.73/ m^2 or serum creatinine >1.5 times the ULN or urine albumin:creatine ratio of >300mg/g at screening.
- Planned surgical procedure over the duration of the study.
- Previous or current history of bleeding diathesis, excessive bleeding or coagulation disorders.
- History of Stevens Johnson Syndrome.
- Participants with active, recurrent or chronic infection (e.g., osteomyelitis), who have been receiving treatment within three months prior to dosing or individuals with an active infection.
- History of significant trauma or surgery to a knee, hip or shoulder within the last 6 months.
- Radiographic evidence of sub-chondral fractures or radiographic abnormalities not consistent with osteoarthritis of the index knee at screening.
- Live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study.
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Intra-articular therapy within 3 months prior to signing the informed consent.
- Immunosuppressant's, including corticosteroids (parenteral within 3 months of screening; oral within 1 month of screening).
- Unable or unwilling to discontinue all pain medication including topical analgesic or adjunctive treatment.
- Major surgery (as per investigator's judgement) within 3 months prior to dosing.
- Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
- Exposure to more than 4 new chemical entities within 12 months prior to the dosing day.
- Current enrolment or past participation in a clinical study of an investigational drug intervention within the last 3 months or 5 half-lives (whichever is longer) of signing consent.
- Positive HIV antibody test.
- Presence of HBsAg at screening.
- Positive Hepatitis C antibody test result.
- Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
- Positive coronavirus (Coronavirus Disease strain 19 [COVID-19]: Severe acute respiratory syndrome- Coronavirus-strain 2 [SARS-CoV-2] polymerase chain reaction [PCR] test of a combined throat and nasopharyngeal swab).
- Clinically significant abnormal ECG at screening, as assessed by the investigator.
- Cardiac troponin or N-terminal pro B-type natriuretic peptide (NT-proBNP) levels out of normal range at screening.
- A positive pre-study drug/alcohol screen at screening.
- Regular alcohol consumption within 6 months prior to signing the informed consent defined as: an average weekly intake of >14 units for males and >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Regular use of known drugs of abuse
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom3 sites
GSK Investigational Site
Cambridge, CB2 2GG
GSK Investigational Site
London, NW10 7EW
GSK Investigational Site
Manchester, M13 9NQ
About this study
Official title: A Two-part Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Intravenous and Subcutaneous Doses of GSK3858279 in Healthy Participants and to Evaluate the Efficacy of Repeat Subcutaneous Doses in Participants With Osteoarthritis of the Knee
This study is the first administration of GSK3858279 in humans and will be conducted in two parts: Part A will consist of a single ascending dose escalation design to evaluate safety, tolerability, PK, TE and immunogenicity of either a single intravenous (IV) or a single subcutaneous (SC) dose. Approximately 48 healthy participants will be enrolled in 6 cohorts and randomized to 3:1 ratio (GSK3858279 or placebo). Part B will evaluate safety, tolerability, efficacy (pain), PK, TE and immunogenicity after repeat SC dosing. Approximately 50 OA participants will be randomized in a parallel group design to receive either GSK3858279 or placebo in a 1:1 ratio.
- Conditions
- Pain, Inflammatory
- Being tested
- GSK3858279 IV, GSK3858279 SC, Placebo matching to GSK3858279 (SC or IV), Placebo matching to GSK3858279 (SC)
- Keywords
- Pain, Osteoarthritis of the knee, Target engagement, GSK3858279, Pharmacokinetics, Sequential
- Medical subject headings
- Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3858279 IVDrug
GSK3858279 will be available as solution for injection to be administered via IV route.
GSK3858279 SCDrug
GSK3858279 will be available as solution for injection to be administered via SC route.
Placebo matching to GSK3858279 (SC or IV)Drug
Placebo will be available as sodium chloride solution to be administered via SC or IV route.
Placebo matching to GSK3858279 (SC)Drug
Placebo will be available as sodium chloride solution to be administered via SC route.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1: GSK3858279 | Experimental | Eligible participants will receive GSK3858279 via IV route. Receives: Drug: GSK3858279 IV |
| Part A: Cohort 2: GSK3858279 | Experimental | Eligible participants will receive GSK3858279 via IV route. Receives: Drug: GSK3858279 IV |
| Part A: Cohort 3: GSK3858279 | Experimental | Eligible participants will receive GSK3858279 via IV route. Receives: Drug: GSK3858279 IV |
| Part A: Cohort 4: GSK3858279 | Experimental | Eligible participants will receive GSK3858279 via IV route. Receives: Drug: GSK3858279 IV |
| Part A: Cohort 5: GSK3858279 | Experimental | Eligible participants will receive GSK3858279 via IV route. Receives: Drug: GSK3858279 IV |
| Part A: Cohort 6: GSK3858279 | Experimental | Eligible participants will receive GSK3858279 via SC route. Receives: Drug: GSK3858279 SC |
| Part A: Placebo | Placebo comparator | Eligible participants will receive placebo matching to GSK3858279 via SC or IV route. Receives: Drug: Placebo matching to GSK3858279 (SC or IV) |
| Part B: GSK3858279 | Experimental | Eligible participants will receive GSK3858279 via SC route. Receives: Drug: GSK3858279 SC |
| Part B: Placebo | Placebo comparator | Eligible participants will receive placebo matching to GSK3858279 via SC route. Receives: Drug: Placebo matching to GSK3858279 (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred on or after the first dose date of study intervention. SAEs is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
Measured: Up to 141 days
Part B: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred on or after the first dose date of study intervention. SAEs is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
Measured: Up to 141 days
Part A: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis
The parameters evaluated for Hematology were Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, mean corpuscular Hg, mean corpuscular volume, Monocytes, Platelet count, Red blood cells, Reticulocytes, Total Neutrophils, White blood cells count (WBC). For Clinical Chemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct bilirubin, Glucose, Potassium, Sodium, Total bilirubin, Total protein, TroponinT, N-terminal pro B-type natriuretic peptide (NT-ProBNP) and Urea. For Urinalysis-Urine bilirubin, Occult blood, Glucose, Ketones, Nitrates, pH, Protein, Specific gravity, Urobilinogen and Leukocyte Esterase for detecting WBC. Changes from baseline in hematology, clinical chemistry and urinalysis were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Measured: Up to 141 days
Part B: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis
The parameters evaluated for Hematology were Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, mean corpuscular Hg, mean corpuscular volume, Monocytes, Platelet count, Red blood cells, Reticulocytes, Total Neutrophils, White blood cells count (WBC). For Clinical Chemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct bilirubin, Glucose, Potassium, Sodium, Total bilirubin, Total protein, TroponinT, N-terminal pro B-type natriuretic peptide (NT-ProBNP) and Urea. For Urinalysis-Urine bilirubin, Occult blood, Glucose, Ketones, Nitrates, pH, Protein, Specific gravity, Urobilinogen and Leukocyte Esterase for detecting WBC. Changes from baseline in hematology, clinical chemistry and urinalysis were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Measured: Up to 141 days
Part A: Number of Participants With Clinically Significant Changes in Electrocardiogram Findings
Twelve-lead Electrocardiogram (ECG) were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, Uncorrected QT and corrected QT intervals (QTc) intervals. Changes from baseline in ECG findings were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Measured: Up to 141 days
Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram Findings
Twelve-lead Electrocardiogram (ECG) were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, Uncorrected QT and corrected QT intervals (QTc) intervals. Changes from baseline in ECG findings were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Measured: Up to 141 days
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Changes from baseline in vital signs were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Measured: Up to 141 days
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Changes from baseline in vital signs were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Measured: Up to 141 days
Part B: Change From Baseline in Knee Pain as Assessed by Average of Daily Pain Numeric Rating Scale at Week 8
Change from Baseline in knee pain due to Osteoarthritis were reported by average of daily pain numeric rating scale (NRS) at Week 8. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average knee pain where 0 indicates no pain, and 10 indicates the worst possible pain. For each participant, the mean pain score prior to each visit was calculated as the average pain intensity in the 7 days prior to assessment visit. Participants were instructed to complete the pain NRS questionnaire at approximately the same time each day. A negative value change from baseline indicates an improvement. Baseline scores for each participant were assigned based on the first dosing visit.
Measured: Baseline (Day 1) and Week 8
Part B: Change From Baseline in Worst Knee Pain Intensity as Assessed by Numeric Rating Scale at Week 8
Change from Baseline in worst knee pain intensity were assessed using NRS at Week 8. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average knee pain where 0 indicated no pain, and 10 indicated worst possible pain. The mean pain score prior to each visit was calculated as the average pain intensity in the 7 days prior to assessment visit. Participants were instructed to complete the pain NRS questionnaire at approximately the same time each day. A negative value change from baseline indicates an improvement. Baseline scores for each participant were assigned based on the first dosing visit.
Measured: Baseline (Day 1) and Week 8
Secondary outcomes (33)
Part A: Serum Concentrations of GSK3858279 Following a Single IV Dose
Measured: Up to 141 days
Part A: Serum Concentrations of GSK3858279 Following a Single SC Dose
Measured: Up to 141 days
Part B: Serum Concentration of GSK3858279 Following Repeat SC Dose
Measured: Up to 141 days
Part A: Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (0-tau) (AUC[0-tau]) Following a Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: AUC From Zero to Time t (0-t) (AUC[0-t]) Following a Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: AUC From Zero to Infinity (0-infinity) (AUC[0-infinity]) Following a Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: AUC(0-tau) Following a Single SC Dose of GSK3858279
Measured: Up to 141 days
Part A: AUC From Zero to Time t (0-t) (AUC[0-t]) Following a Single SC Dose of GSK3858279
Measured: Up to 141 days
Part A: AUC From Zero to Infinity (0-infinity) (AUC[0-infinity]) Following a Single SC Dose of GSK3858279
Measured: Up to 141 days
Part B: AUC(0-tau) Following a Repeat SC Dose of GSK3858279
Measured: Baseline and Week 8
Part B: AUC(0-t) Following a Repeat SC Dose of GSK3858279
Measured: Up to 141 days
Part B: AUC(0-infinity) Following a Repeat SC Dose of GSK3858279
Measured: Up to 141 days
Part A: Maximum Concentration (Cmax) After a Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: Maximum Concentration (Cmax) After a Single SC Dose of GSK3858279
Measured: Up to 141 days
Part B: Cmax After Repeat SC Dose of GSK3858279
Measured: Baseline and Week 8
Part A: Half-life (t1/2) Following a Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: Half-life (t1/2) Following a Single SC Dose of GSK3858279
Measured: Up to 141 days
Part B: t1/2 Following a Repeat SC Dose of GSK3858279
Measured: Up to 141 days
Part A: Clearance (CL) Following a Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: Clearance (CL) Following a Single SC Dose of GSK3858279
Measured: Up to 141 days
Part B: CL Following a Repeat SC Dose of GSK3858279
Measured: Up to 141 days
Part A: Volume of Distribution at Steady State (Vss) Following a Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: Volume of Distribution at Steady State (Vss) Following a Single SC Dose of GSK3858279
Measured: Up to 141 days
Part B: Vss Following a Repeat SC Dose of GSK3858279
Measured: Up to 141 days
Part A: Volume of Distribution (V) Following a Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: Volume of Distribution (V) Following a Single SC Dose of GSK3858279
Measured: Up to 141 days
Part B: Volume of Distribution (V) Following a Repeat SC Dose of GSK3858279
Measured: Up to 141 days
Part A: Free Chemokine Ligand 17 (CCL17) Levels in Serum Following Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: CCL17 Levels in Serum Following Single SC Dose of GSK3858279
Measured: Up to 141 days
Part B: Free CCL17 Levels in Serum Following Repeat SC Dose of GSK3858279
Measured: Up to 141 days
Part A: Total CCL17 Levels in Serum Following Single IV Dose of GSK3858279
Measured: Up to 141 days
Part A: Total CCL17 Levels in Serum Following Single SC Dose of GSK3858279
Measured: Up to 141 days
Part B: Total CCL17 Levels in Serum Following Repeat SC Dose of GSK3858279
Measured: Up to 141 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start17 May 2018
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, InflammatoryStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants will be randomized in 3:1 ratio to receive GSK3858279 and placebo in sequential manner in Part A. In Part B, participants will be randomized in parallel groups to receive either GSK3858279 or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485365
- Sponsor's protocol ID
- 207804
- Other IDs
- 2017-004809-41, 2017
- Status last verified
- Sep 2023
- First submitted
- 27 Mar 2018
- Last updated
- 22 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Intravenous and Subcutaneous Doses of GSK3858279 in Healthy Participants and to Evaluate the Efficacy of Repeat Subcutaneous Doses in Participants With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03485365
- Acronym / sponsor ID
- 207804
- Conditions
- Pain, Inflammatory
- Keywords
- Pain, Osteoarthritis of the knee, Target engagement, GSK3858279, Pharmacokinetics, Sequential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Posted 22 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is the first administration of GSK3858279 in humans and will be conducted in two parts: Part A will consist of a single ascending dose escalation design to evaluate safety, tolerability, PK, TE and immunogenicity of either a single intravenous (IV) or a single subcutaneous (SC) dose. Approximately 48 healthy participants will be enrolled in 6 cohorts and randomized to 3:1 ratio (GSK3858279 or placebo). Part B will evaluate safety, tolerability, efficacy (pain), PK, TE and immunogenicity after repeat SC dosing. Approximately 50 OA participants will be randomized in a parallel group design to receive either GSK3858279 or placebo in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- Model description
- Participants will be randomized in 3:1 ratio to receive GSK3858279 and placebo in sequential manner in Part A. In Part B, participants will be randomized in parallel groups to receive either GSK3858279 or placebo.
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1: GSK3858279 | Experimental | Drug: GSK3858279 IVEligible participants will receive GSK3858279 via IV route. |
| Part A: Cohort 2: GSK3858279 | Experimental | Drug: GSK3858279 IVEligible participants will receive GSK3858279 via IV route. |
| Part A: Cohort 3: GSK3858279 | Experimental | Drug: GSK3858279 IVEligible participants will receive GSK3858279 via IV route. |
| Part A: Cohort 4: GSK3858279 | Experimental | Drug: GSK3858279 IVEligible participants will receive GSK3858279 via IV route. |
| Part A: Cohort 5: GSK3858279 | Experimental | Drug: GSK3858279 IVEligible participants will receive GSK3858279 via IV route. |
| Part A: Cohort 6: GSK3858279 | Experimental | Drug: GSK3858279 SCEligible participants will receive GSK3858279 via SC route. |
| Part A: Placebo | Placebo comparator | Drug: Placebo matching to GSK3858279 (SC or IV)Eligible participants will receive placebo matching to GSK3858279 via SC or IV route. |
| Part B: GSK3858279 | Experimental | Drug: GSK3858279 SCEligible participants will receive GSK3858279 via SC route. |
| Part B: Placebo | Placebo comparator | Drug: Placebo matching to GSK3858279 (SC)Eligible participants will receive placebo matching to GSK3858279 via SC route. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body weight within the range 50 to 100 kilogram (kg) and body mass index (BMI) within the range 18 to 32 kilogram per meter square (kg/m^2) (inclusive).
- Male participants are eligible to participate if they agree to the following for at least 28 weeks after the dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier as detailed below: agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- A female participant is eligible to participate if she is of non-reproductive potential.
Key exclusion criteria (86 listed)
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Personal or family history of cardiomyopathy.
- Abnormal blood pressure at screening as determined by the investigator.
- History of symptomatic herpes zoster.
- Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK3858279 IVGSK3858279 will be available as solution for injection to be administered via IV route. | Drug | Part A: Cohort 1: GSK3858279, Part A: Cohort 2: GSK3858279, Part A: Cohort 3: GSK3858279, Part A: Cohort 4: GSK3858279, Part A: Cohort 5: GSK3858279 |
| GSK3858279 SCGSK3858279 will be available as solution for injection to be administered via SC route. | Drug | Part A: Cohort 6: GSK3858279, Part B: GSK3858279 |
| Placebo matching to GSK3858279 (SC or IV)Placebo will be available as sodium chloride solution to be administered via SC or IV route. | Drug | Part A: Placebo |
| Placebo matching to GSK3858279 (SC)Placebo will be available as sodium chloride solution to be administered via SC route. | Drug | Part B: Placebo |
Primary outcome
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 141 days
An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred on or after the first dose date of study intervention. SAEs is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
Part B: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Time frame: Up to 141 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred on or after the first dose date of study intervention. SAEs is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
Part A: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis
Time frame: Up to 141 days
The parameters evaluated for Hematology were Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, mean corpuscular Hg, mean corpuscular volume, Monocytes, Platelet count, Red blood cells, Reticulocytes, Total Neutrophils, White blood cells count (WBC). For Clinical Chemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct bilirubin, Glucose, Potassium, Sodium, Total bilirubin, Total protein, TroponinT, N-terminal pro B-type natriuretic peptide (NT-ProBNP) and Urea. For Urinalysis-Urine bilirubin, Occult blood, Glucose, Ketones, Nitrates, pH, Protein, Specific gravity, Urobilinogen and Leukocyte Esterase for detecting WBC. Changes from baseline in hematology, clinical chemistry and urinalysis were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Part B: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis
Time frame: Up to 141 days
The parameters evaluated for Hematology were Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, mean corpuscular Hg, mean corpuscular volume, Monocytes, Platelet count, Red blood cells, Reticulocytes, Total Neutrophils, White blood cells count (WBC). For Clinical Chemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct bilirubin, Glucose, Potassium, Sodium, Total bilirubin, Total protein, TroponinT, N-terminal pro B-type natriuretic peptide (NT-ProBNP) and Urea. For Urinalysis-Urine bilirubin, Occult blood, Glucose, Ketones, Nitrates, pH, Protein, Specific gravity, Urobilinogen and Leukocyte Esterase for detecting WBC. Changes from baseline in hematology, clinical chemistry and urinalysis were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Part A: Number of Participants With Clinically Significant Changes in Electrocardiogram Findings
Time frame: Up to 141 days
Twelve-lead Electrocardiogram (ECG) were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, Uncorrected QT and corrected QT intervals (QTc) intervals. Changes from baseline in ECG findings were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram Findings
Time frame: Up to 141 days
Twelve-lead Electrocardiogram (ECG) were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, Uncorrected QT and corrected QT intervals (QTc) intervals. Changes from baseline in ECG findings were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to 141 days
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Changes from baseline in vital signs were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to 141 days
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Changes from baseline in vital signs were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.
Part B: Change From Baseline in Knee Pain as Assessed by Average of Daily Pain Numeric Rating Scale at Week 8
Time frame: Baseline (Day 1) and Week 8
Change from Baseline in knee pain due to Osteoarthritis were reported by average of daily pain numeric rating scale (NRS) at Week 8. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average knee pain where 0 indicates no pain, and 10 indicates the worst possible pain. For each participant, the mean pain score prior to each visit was calculated as the average pain intensity in the 7 days prior to assessment visit. Participants were instructed to complete the pain NRS questionnaire at approximately the same time each day. A negative value change from baseline indicates an improvement. Baseline scores for each participant were assigned based on the first dosing visit.
Part B: Change From Baseline in Worst Knee Pain Intensity as Assessed by Numeric Rating Scale at Week 8
Time frame: Baseline (Day 1) and Week 8
Change from Baseline in worst knee pain intensity were assessed using NRS at Week 8. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average knee pain where 0 indicated no pain, and 10 indicated worst possible pain. The mean pain score prior to each visit was calculated as the average pain intensity in the 7 days prior to assessment visit. Participants were instructed to complete the pain NRS questionnaire at approximately the same time each day. A negative value change from baseline indicates an improvement. Baseline scores for each participant were assigned based on the first dosing visit.
33 secondary outcomes
Part A: Serum Concentrations of GSK3858279 Following a Single IV Dose
Time frame: Up to 141 days
Part A: Serum Concentrations of GSK3858279 Following a Single SC Dose
Time frame: Up to 141 days
Part B: Serum Concentration of GSK3858279 Following Repeat SC Dose
Time frame: Up to 141 days
Part A: Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (0-tau) (AUC[0-tau]) Following a Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: AUC From Zero to Time t (0-t) (AUC[0-t]) Following a Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: AUC From Zero to Infinity (0-infinity) (AUC[0-infinity]) Following a Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: AUC(0-tau) Following a Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part A: AUC From Zero to Time t (0-t) (AUC[0-t]) Following a Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part A: AUC From Zero to Infinity (0-infinity) (AUC[0-infinity]) Following a Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part B: AUC(0-tau) Following a Repeat SC Dose of GSK3858279
Time frame: Baseline and Week 8
Part B: AUC(0-t) Following a Repeat SC Dose of GSK3858279
Time frame: Up to 141 days
Part B: AUC(0-infinity) Following a Repeat SC Dose of GSK3858279
Time frame: Up to 141 days
Part A: Maximum Concentration (Cmax) After a Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: Maximum Concentration (Cmax) After a Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part B: Cmax After Repeat SC Dose of GSK3858279
Time frame: Baseline and Week 8
Part A: Half-life (t1/2) Following a Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: Half-life (t1/2) Following a Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part B: t1/2 Following a Repeat SC Dose of GSK3858279
Time frame: Up to 141 days
Part A: Clearance (CL) Following a Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: Clearance (CL) Following a Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part B: CL Following a Repeat SC Dose of GSK3858279
Time frame: Up to 141 days
Part A: Volume of Distribution at Steady State (Vss) Following a Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: Volume of Distribution at Steady State (Vss) Following a Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part B: Vss Following a Repeat SC Dose of GSK3858279
Time frame: Up to 141 days
Part A: Volume of Distribution (V) Following a Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: Volume of Distribution (V) Following a Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part B: Volume of Distribution (V) Following a Repeat SC Dose of GSK3858279
Time frame: Up to 141 days
Part A: Free Chemokine Ligand 17 (CCL17) Levels in Serum Following Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: CCL17 Levels in Serum Following Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part B: Free CCL17 Levels in Serum Following Repeat SC Dose of GSK3858279
Time frame: Up to 141 days
Part A: Total CCL17 Levels in Serum Following Single IV Dose of GSK3858279
Time frame: Up to 141 days
Part A: Total CCL17 Levels in Serum Following Single SC Dose of GSK3858279
Time frame: Up to 141 days
Part B: Total CCL17 Levels in Serum Following Repeat SC Dose of GSK3858279
Time frame: Up to 141 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK3858279 IV and GSK3858279 SC in people with Pain, Inflammatory, run by GlaxoSmithKline at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 86 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to 141 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.